In this Background Paper a to the 2013 Priority Medicines Report we describe
developments in the system for marketing authorization of new medicines related
to pharmaceutical innovation and meeting priority health care needs. In order to
support the development of innovative medicines, and to properly address health
care needs we propose research priorities for the regulatory system in the
coming years. We consider relevant developments at four levels: the overall
system of marketing authorization; key components of the system; specific
regulations within the system; and broader developments surrounding the system.